Dr. Mihales Polymeropoulos, President and CEO of Vanda Pharmaceuticals, Inc. announced in a press release today that Vanda has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for Iloperidone, an investigational atypical antipsychotic treatment for schizophrenia. In 35 clinical trials with more than 3,000 patients, Iloperidone was used effectively, with decreased side effects, to treat symptoms of schizophrenia both in acute and chronic settings.
“The submission of the Iloperidone New Drug Application marks a significant milestone for Vanda. Iloperidone may become an important instrument in the treatment of patients with schizophrenia and may help to usher the field of psychiatry into an era of personalized medicine.” Dr. Polymeropoulos explained. Existing treatments for schizophrenia have varying levels of success for patients and some patients suffering from schizophrenia have to discontinue the treatments.
According to Michael Fitzpatrick, Executive Director of the National Alliance on Mental Illness, “Advancements in personalized medicine could change the treatment paradigm for schizophrenia, and possibly other mental illnesses.” Officials from Vanda indicate that they are developing and studying Iloperidone for not only schizophrenia, but also bipolar disorder and other psychiatric conditions.
Current Antipsychotic Treatments vs. Iloperidone
Patients using current antipsychotic drugs often experience side effects such as weight gain, diabetes, extrapyramidal symptoms, hyperprolactinemia, increased somnolence and cognition difficulties. A study done by the National Institute of Mental Health found that 74% of patients taking antipsychotics discontinued treatment within 18 months.
Vanda believes the approval of Iloperidone may end the “trial-and-error” treatments of schizophrenia. Some patients have a common mutation of a gene linked to central nervous system function, that is estimated to occur in approximately 70% of schizophrenia patients. They found in clinical studies that certain patients may be more likely to respond to Iloperidone relative to the general schizophrenia patient population.
Studies done by Vanda indicate that Iloperidone, if approved for regulatory use, may have other distinct advantages over current antipsychotic medications used to treat schizophrenia and mental disorders:
In short and long term trials, Iloperidone was associated with low weight gain, no induction of diabetes, low extrapyramidal symptoms, no akathisia, no hyperprolactinemia, low incidence of sleepiness and low negative effects on cognition relative to placebo. Iloperidone was found to be associated with a prolongation of the heart’s QTc interval to an extent similar to that of Geodon.
Vanda is developing an injectable form of Iloperidone used once every four weeks that during trials, showed no greater side effects than the oral form.
Vanda Pharmaceuticals Submits Iloperidone New Drug Application